Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094088267
• Version / Model: 901029
• Catalog Number: 14012
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-05
• Public Version: 4
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: cb51608c-1da9-4bb3-a9b2-44229f0a46ae

Device Description

Welch Allyn SureSight Autorefractor; Automatically screens for common vision problems, including near and farsightedness (myopia/hyperopia), astigmatism (asymmetrical focus), and anisometropia (unequal power between eyes); Degree in Axis Readings, Charging Base, Thermal Printer, Storage Case; 230 V, 50 Hz AC, Lithium-Ion (#72420) Battery; IEC Plug

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKO	Refractometer, ophthalmic	Ophthalmic	886.1760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65177	Vision physiology/eye movement analysis system	An electronic unit or device assembly intended to measure, record, and display a range of ophthalmic parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation; it is neither intended to measure dimensional/ocular-shape parameters nor is it dedicated to neurological assessment. Features may include visual stimuli (e.g., light/image patterns) and/or sensing/tracking devices (e.g., bioelectric amplifiers, cameras).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094088267	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]